Tips on how to manage low endotoxin recovery

Lonza has announced a resource that addresses a key topic of debate in the endotoxin detection community — low endotoxin recovery (LER).

LER has been defined as the masking of endotoxin in undiluted biological drug products, such as monoclonal antibodies, vaccines and other protein products, and has been linked to the use of polysorbate in conjunction with a chelating buffer — specifically citrate and phosphate buffers. Lonza provides QC professionals with details on how to recognise LER in a process/product and what the limulus amebocyte lysate (LAL) community is doing to help drug manufacturers who experience LER.

The archived webinar ‘Low Endotoxin Recovery (LER) — Context and Resolution from a Broad Biologics Test Perspective’ delivers the latest information and guidance about this phenomenon. ‘Low Endotoxin Recovery (LER) Frequently Asked Questions’ is meanwhile available as part of the company’s QC Insider Toolbox — an internet portal offering comprehensive support tools, training resources and a library of information that will help QC professionals achieve success in bacterial endotoxins testing.

“These LER resources in our QC Insider Toolbox — including the new Tech Tip sheet — not only provide guidance for the end user on the FDA’s current position on LER, but also include recommendations for performing hold-time studies and information on the use of naturally occurring endotoxin (NOE),” said Katrin Hoeck, head of marketing analysis and testing at Lonza Bioscience Solutions.

To access the webinar or sign up as a QC Insider, visit http://www.lonza.com/qcinsider.